For Merck Serono, Two's the Charm

Nearly 8 months after the FDA refused to file Merck Serono's application for oral cladribine as an MS treatment, the company says the drug has now received priority review.* Merck Serono resubmitted its application to the agency in June. Related coverage from the WSJ indicates that the company expects an FDA decision in the fourth quarter, although the goal for a priority review is a bit longer, at 6 months.

With cladribine, Merck Serono has been in a nose-to-nose horse race with Novartis, which is developing fingolimod (Gilenia). One of these companies is very likely to be the first to offer an FDA-approved, orally administered disease-modifying drug for the relapsing-remitting form of the disease. (Current, approved, disease-modifying medications for RRMS, like interferon beta, are injected subcutaneously or intramuscularly.)

According to the WSJ and Reuters, oral cladribine for RRMS was approved in Russia earlier this month and is awaiting a nod in Europe. In June, an FDA panel voted overwhelmingly in favor of fingolimod's approval—at least with respect to its efficacy. Safety issues with Novartis's agent include opportunistic infections, and analysts have speculated that the FDA will institute some kind of access-limiting REMS program for the drug, if/once it is approved.

A new survey analysis indicates that US neurologists are considerably more aware of cladribine than fingolimod—probably because the former has been available as an injectable anticancer drug since the Stone Age (ie, the early 1990s), and fingolimod is a new molecular entity (NME).

MS = multiple sclerosis; REMS = Risk Evaluation and Mitigation Strategies.

* According to the FDA, a "Priority Review designation is given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. A Priority Review means that the time it takes FDA to review a new drug application is reduced. The goal for completing a Priority Review is six months."